Percutaneous transvalvular intraannular band for mitral valve repair

ABSTRACT

Mitral valve prolapse and mitral regurgitation can be treating by implanting in the mitral annulus a transvalvular intraannular band. The band has a first end, a first anchoring portion located proximate the first end, a second end, a second anchoring portion located proximate the second end, and a central portion. The central portion is positioned so that it extends transversely across a coaptive edge formed by the closure of the mitral valve leaflets. The band may be implanted via translumenal access or via thoracotomy.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/361,694 filed on Mar. 22, 2019 and currently pending, which is inturn is a continuation of U.S. patent application Ser. No. 15/295,204filed on Oct. 17, 2016, now issued as U.S. Pat. No. 10,238,488, which isin turn a continuation of U.S. patent application Ser. No. 14/628,114filed on Feb. 20, 2015, now issued as U.S. Pat. No. 9,468,526, which isin turn a continuation of U.S. patent application Ser. No. 13/650,998filed on Oct. 12, 2012, now issued as U.S. Pat. No. 8,961,597, which isin turn a continuation of U.S. patent application Ser. No. 12/579,330filed Oct. 14, 2009, now abandoned, which is a continuation-in-part ofU.S. patent application Ser. No. 12/104,011 filed Apr. 16, 2008 andissued as U.S. Pat. No. 8,262,725 on Sep. 11, 2012, the disclosure ofwhich is incorporated by reference herein in its entirety.

BACKGROUND OF THE INVENTION Field of the Invention

Embodiments of the present invention relate generally to treatment ofmitral or tricuspid valve prolapse and mitral regurgitation, and morespecifically, relate to the use of a transvalvular intraannular band totreat mitral valve prolapse and mitral regurgitation.

Description of the Related Art

The heart is a double (left and right side), self-adjusting muscularpump, the parts of which work in unison to propel blood to all parts ofthe body. The right side of the heart receives poorly oxygenated(“venous”) blood from the body from the superior vena cava and inferiorvena cava and pumps it through the pulmonary artery to the lungs foroxygenation. The left side receives well-oxygenated (“arterial”) bloodfrom the lungs through the pulmonary veins and pumps it into the aortafor distribution to the body.

The heart has four chambers, two on each side—the right and left atria,and the right and left ventricles. The atria are the blood-receivingchambers, which pump blood into the ventricles. A wall composed ofmembranous and muscular parts, called the interatrial septum, separatesthe right and left atria. The ventricles are the blood-dischargingchambers. A wall composed of membranous and muscular parts, called theinterventricular septum, separates the right and left ventricles.

The synchronous pumping actions of the left and right sides of the heartconstitute the cardiac cycle. The cycle begins with a period ofventricular relaxation, called ventricular diastole. The cycle ends witha period of ventricular contraction, called ventricular systole.

The heart has four valves that ensure that blood does not flow in thewrong direction during the cardiac cycle; that is, to ensure that theblood does not back flow from the ventricles into the correspondingatria, or back flow from the arteries into the corresponding ventricles.The valve between the left atrium and the left ventricle is the mitralvalve. The valve between the right atrium and the right ventricle is thetricuspid valve. The pulmonary valve is at the opening of the pulmonaryartery. The aortic valve is at the opening of the aorta.

Various disease processes can impair the proper functioning of one ormore of these valves. These include degenerative processes (e.g.,Barlow's Disease, fibroelastic deficiency), inflammatory processes(e.g., Rheumatic Heart Disease) and infectious processes (e.g.,endocarditis). In addition, damage to the ventricle from prior heartattacks (i.e., myocardial infarction secondary to coronary arterydisease) or other heart diseases (e.g., cardiomyopathy) can distort thevalve's geometry causing it to dysfunction.

The mitral valve is comprised of an anterior leaflet and a posteriorleaflet. The bases of the leaflets are fixed to a circumferential partlyfibrous structure, the annulus, preventing dehiscence of the valve. Asubvalvular apparatus of chordae and papillary muscles prevents thevalve from prolapsing into the left atrium. Mitral valve disease can beexpressed as a complex variety of pathological lesions of either valveor subvalvular structures, but can also be related to the functionalstatus of the valve. Functionally the mitral valve disease can becategorized into two anomalies, increased leaflet motion i.e. leafletprolapse leading to regurgitation, or diminished leaflet motion i.e.restricted leaflet motion leading to obstruction and/or regurgitation ofblood flow.

Leaflet prolapse is defined as when a portion of the leaflet overridesthe plane of the orifice during ventricular contraction. The mitralregurgitation can also develop secondary to alteration in the annularventricular apparatus and altered ventricular geometry, followed byincomplete leaflet coaptation. In ischemic heart failure this can beattributed to papillary or lateral wall muscle dysfunction, and innon-ischemic heart failure it can be ascribed to annular dilation andchordal tethering, all as a result of dysfunctional remodeling.

The predominant cause of dysfunction of the mitral valve isregurgitation which produces an ineffective cardiac pump functionresulting in several deleterious conditions such as ventricular andatrial enlargement, pulmonary hypertension and heart-failure andultimately death.

The main objective for the surgical correction is to restore normalfunction and not necessarily anatomical correction. This is accomplishedby replacing the valve or by reconstructing the valve. Both of theprocedures require the use of cardiopulmonary bypass and is a majorsurgical operation carrying a non-negligible early morbidity andmortality risk, and a postoperative rehabilitation for months withsubstantial postoperative pain. Historically, the surgical approach topatients with functional mitral regurgitation was mitral valvereplacement, however with certain adverse consequences such asthromboembolic complications, the need for anticoagulation, insufficientdurability of the valve, loss of ventricular function and geometry.

Reconstruction of the mitral valve is therefore the preferred treatmentfor the correction of mitral valve regurgitation and typically consistsof a quadrangular resection of the posterior valve (valvuloplasty) incombination with a reduction of the mitral valve annulus (annuloplasty)by the means of suturing a ring onto the annulus. These procedures aresurgically demanding and require a bloodless and well-exposed operatingfield for an optimal surgical result. The technique has virtually notbeen changed for more than three decades.

More recently, prolapse of the valve has been repaired by anchoring thefree edge of the prolapsing leaflet to the corresponding free edge ofthe opposing leaflet and thereby restoring apposition but notnecessarily coaptation. In this procedure a ring annuloplasty is alsorequired to attain complete coaptation.

This method commonly referred to as an edge-to-edge or “Alfieri” repairalso has certain drawbacks such as the creation of a double orificevalve and thereby reducing the effective orifice area. Several lessinvasive approaches related to the edge-to-edge technique has beensuggested, for repairing mitral valve regurgitation by placing a clipthrough a catheter to suture the valve edges. However, it still remainsto conduct an annuloplasty procedure, which has not yet been resolved bya catheter technique and therefore is to be performed by conventionalsurgery, which makes the method impractical.

Notwithstanding the presence of a variety of presently availablesurgical techniques and promising catheter based procedures for thefuture, there remains a need for a simple but effective device andcorresponding surgical, minimally invasive or transvascular procedure toreduce mitral valve regurgitation.

SUMMARY OF THE INVENTION

Further features and advantages of the present invention will becomeapparent to those of skill in the art in view of the detaileddescription of preferred embodiments which follows, when consideredtogether with the attached drawings and claims.

Some embodiments of this invention are directed to a transvalvularintraannular band to treat mitral valve prolapse and mitralregurgitation. The terminology “transvalvular” as used hereinencompasses “across”, “over”, or “through” the valve surfaces by anymeans, and “intraannular” provides an axial spatial reference to withinthe native valve annulus or an annular band that serves to functionwithin the valve annulus. Axial with respect to the valve axis meansalong the axis of the valve and can describe position relative to theatrium, “supra”, or relative to the ventricle, “infra”. Specifically, itcreates an axis through which a plane is pierced by the aforementionedaxis, and encompasses an embodiment that is intraannular to addresscoaptation at the valvular plane or series of valvular planes createdduring each cardiac cycle, but does not obviate other salient featuresof the invention that may be clearly infraannular or supraannular duringthe cardiac cycle. Further, the terminology in the followingdescriptions may use “transannular band” or “band” and it means toinclude all features that may be infraannular, intraannular, orsuprannular without or with stating each axially descriptive term. Aswell “offset” refers to directionally displaced from a frame ofreference.

In some embodiments, disclosed herein is a method of delivering atransvalvular intraannular implant. The method includes the steps ofproviding a delivery catheter, the delivery catheter comprising anelongate body; a movable outer sheath; and a transvalvular intraannularimplant having a longitudinal axis and comprising a valve leafletsupport portion and an anchoring portion, the valve leaflet supportportion at least partially longitudinally offset from the anchoringportion; percutaneously delivering the delivery catheter to the vicinityof a heart valve annulus; transforming the implant from a first radiallyreduced configuration to a second radially enlarged configuration; andpositioning the implant in its second radially enlarged configurationwithin the heart valve annulus such that the implant is oriented in thevalve annulus such that the longitudinal axis of the implant is orientedsubstantially transversely to a coaptive edge of a heart valvepositioned within the valve annulus. The heart valve annulus can be, forexample, a mitral, aortic, tricuspid, or pulmonary valve annulus. Insome embodiments, transforming the implant from the first radiallyreduced configuration to the second radially enlarged configurationcomprises retracting or pushing forward the movable outer sheath of thedelivery catheter, exposing the implant. The delivery catheter canfurther include a self-expandable support structure, such as a ring orstent for example, operably connected to the transvalvular implant.Percutaneously delivering the delivery catheter to the vicinity of thevalve annulus can include one or more of approaching the valve annulusfrom a supraannular location, infraannular location, cardiac septum,such as the intra-atrial or intra-ventricular septum, a vascularcut-down, or a thoracoscopic procedure. The anchoring portion of theimplant can be secured to tissue of the valve annulus, such as passing atissue anchor through the anchoring portion of the implant and tissue ofthe valve annulus. In some embodiments, providing a delivery catheterincludes providing a control wire operably attached to the implant, andpositioning the implant includes applying tension to the control wire tomove the implant. The control wire can be detached from the implantafter being properly positioned, in some embodiments.

Also disclosed herein is a transvalvular intraannular delivery system.The system includes a percutaneous delivery catheter comprising anelongate body; a movable outer sheath; and a transvalvular intraannularimplant having a longitudinal axis and comprising a valve leafletsupport portion and an anchoring portion, the valve leaflet supportportion at least partially longitudinally offset from the anchoringportion, wherein the transvalvular implant is configured to betransformable from a first radially reduced configuration to a secondradially enlarged configuration; wherein the transvalvular implant isconfigured to be housed within the percutaneous delivery catheter in itsfirst radially reduced configuration, wherein the transvalvular implantis configured to be positioned in its second radially enlargedconfiguration within a heart valve annulus such that the implant isoriented in the valve annulus such that the longitudinal axis of theimplant is oriented substantially transversely to a coaptive edge of aheart valve positioned within the valve annulus. The system can alsoinclude a control wire operably attached to the implant for positioningthe implant within the heart valve annulus. In some embodiments, thesystem also includes at least one tissue anchor for attaching theimplant to tissue of the valve annulus. In some embodiments, the systemalso includes a self-expandable support structure operably connected tothe transvalvular implant, for securing the implant to tissue of thevalve annulus.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified cross-sectional view of the heart with a normalmitral valve during systole. The intraaannular plane is illustratedrelative to supraannular and infrannular.

FIG. 2 is a cross-sectional view of the heart with a normal mitral valveduring diastole. The axis of the mitral valve is illustrated, and shownpiercing the intraannular plane.

FIG. 3 is a bottom view of the normal mitral valve of FIG. 1 duringsystole looking from the left atrium to the left ventricle.

FIG. 4 is a bottom view of the normal mitral valve of FIG. 2 duringdiastole looking from the left atrium to the left ventricle.

FIG. 5 is a cross-sectional schematic view of the normal mitral valve ofFIG. 1 during systole, illustrating the depth of the coaption zone.

FIG. 6 is a cross-sectional schematic view of the normal mitral valve ofFIG. 2 during diastole.

FIG. 7 is a cross-sectional view of the heart during systole showing amitral valve with a prolapsed anterior leaflet caused by the rupture ofthe chordae tendineae attached to the anterior leaflet.

FIG. 8 is a bottom view of the mitral valve of FIG. 7 having a prolapsedanterior leaflet looking from the left atrium to the left ventricle.

FIG. 9 is a cross-sectional view of the heart during systole showing amitral valve with a prolapsed posterior leaflet caused by the rupture ofthe chordae tendineae attached to the posterior leaflet.

FIG. 10 is a bottom view of the mitral valve of FIG. 9 having aprolapsed posterior leaflet looking from the left atrium to the leftventricle.

FIG. 11 is a cross-sectional view of the heart during systole showing amitral valve with anterior leaflet prolapse.

FIG. 11A is a cross sectional view as in FIG. 11, showing posteriorleaflet prolapse.

FIG. 11B is a cross sectional view as in FIG. 11, showing bileafletprolapse with mitral regurgitation.

FIG. 11C illustrates a dilated mitral annulus with little or no coaptionof both leaflets causing central mitral regurgitation in ischemiccardiomyopathy.

FIG. 12 is a top view of an embodiment of a transvalvular band.

FIG. 13 is a side view of the transvalvular band of FIG. 12.

FIG. 14 is a cross-sectional view of a transvalvular band with atriangular cross-section.

FIG. 15 is a cross-sectional view of a transvalvular band with an oblongcross-section.

FIG. 16 is a cross-sectional view of a transvalvular band with acircular cross-section.

FIG. 17 is a cross-sectional view of a transvalvular band with arectangular cross-section.

FIG. 18 is a top view of another embodiment of a transvalvular band.

FIGS. 19A and B show a perspective view of yet another embodiment of atransvalvular band, with a widened coaptive edge support portion.

FIGS. 20-23 are top views of other embodiments of a transvalvular band.

FIG. 23A shows a central mitral transvalvular band with posteriorannuloplasty ring.

FIG. 23B shows an intraannular band formed from a length of wire.

FIGS. 24-27 are side views of other embodiments of a transvalvular band.

FIG. 28 is a cross-sectional view of a heart during systole with atransvalvular band implanted in the mitral annulus.

FIG. 29 is a bottom view of the mitral valve of FIG. 28 during systolewith a transvalvular band implanted in the mitral annulus looking fromthe left atrium to the left ventricle.

FIG. 30 is a cross-sectional view of a heart during diastole with mitralvalve and a transvalvular band implanted in the mitral annulus.

FIG. 31 is a bottom view of the mitral valve of FIG. 30 during diastolewith a transvalvular band implanted in the mitral annulus looking fromthe left atrium to the left ventricle.

FIG. 32 is a cross-sectional schematic view of the mitral valve of FIG.28 during systole with a transvalvular band implanted in the mitralannulus.

FIG. 33 is a cross-sectional schematic view of the mitral valve of FIG.32 during systole without the transvalvular band implanted in the mitralannulus.

FIG. 34 is a cross-sectional schematic view of the mitral valve of FIG.30 during diastole with the transvalvular band implanted in the mitralannulus.

FIG. 35 is a cross-sectional schematic view of the mitral valve of FIG.34 during diastole without the transvalvular band implanted in themitral annulus.

FIG. 36 is a bottom view of the mitral valve during systole with anotherembodiment of the transvalvular band implanted in the mitral annuluslooking from the left atrium to the left ventricle.

FIG. 37 is a cross-sectional view of a transvalvular band with atransverse leaflet support.

FIG. 38 is a cross-sectional schematic view of the mitral valve treatedwith the transvalvular band of FIG. 37 and an Alfieri type procedure.

FIG. 39 is a schematic cross-sectional view of the heart, showing atypical antegrade approach to the mitral valve by way of a transseptalcrossing.

FIG. 40 is a cross sectional view as in FIG. 39, showing placement of aguidewire through the mitral valve.

FIG. 41 is a cross sectional view of the heart showing a typicalretrograde approach to the mitral valve by way of a femoral arteryaccess.

FIG. 42 shows a retrograde approach as in FIG. 41, with a guidewireplaced across the mitral valve.

FIG. 43A is a schematic view of the distal end of a percutaneousdeployment catheter having a self-expandable implant positioned therein.

FIG. 43B is a schematic view as in FIG. 43A, with the implant partiallydeployed from the catheter.

FIG. 43C is a schematic view of the deployment catheter showing theimplant fully expanded at the deployment site, but still tethered to thedeployment catheter.

FIG. 43D is a side elevational view of the implant of FIG. 43C.

FIG. 43E is an end view taken along the line 43E-43E of FIG. 43D.

FIG. 44A is a side elevational perspective view of an anchor deploymentcatheter in accordance with the present invention.

FIG. 44B is a cross sectional view taken along the line 44B-44B of FIG.44A.

FIG. 44C is a cross sectional side view of the anchor deploymentcatheter of FIG. 44A.

FIG. 45A is a schematic plan view of a self-expandable transvalvularband in accordance with the present invention.

FIG. 45B is a side elevational view of the transvalvular band of FIG.45A shown in a reduced crossing profile (folded) configuration, andattached to three control wires.

FIG. 46A is a cut-away perspective view of the distal end of adeployment catheter having a self-expandable implant contained therein.

FIG. 46B is a deployment catheter as in FIG. 46A, with the implantpartially deployed.

FIG. 46C is a view as in FIG. 46B, showing the implant released from thedeployment catheter, but connected to three control wires.

FIG. 46D is a view as in FIG. 46C with a tissue anchor deploymentcatheter.

FIG. 46E is a cross sectional view of a mitral valve, having an implantanchored in place and the deployment catheter removed.

FIG. 47A is a side elevational view of the distal end of a deploymentcatheter, having an implant partially deployed therefrom.

FIG. 47B is a schematic view of the catheter and implant of FIG. 47A,during implantation at the mitral valve.

FIG. 47C is a schematic view as in FIG. 47B, with the tissue anchordeployment guides removed.

FIG. 47D is a schematic view as in FIG. 47C, with the implant configuredto move coaption earlier in the cardiac cycle.

FIG. 47E is a schematic view of the implant of FIG. 47D, with thedeployment catheter removed.

FIG. 48A is schematic cross sectional view of a transapical deploymentdevice positioned across the mitral valve.

FIG. 48B is a schematic view of the device of FIG. 48A, with tissueanchors engaged at the mitral valve annulus.

FIG. 48C is a schematic view as in FIG. 48B, with the deploymentcatheter withdrawn through the mitral valve.

FIG. 48D is a schematic view as in FIG. 48C, in an embodiment having atransventricular support.

FIGS. 49A through 49G illustrate an implantation sequence for atransvalvular band at the mitral valve, via a transapical access.

FIG. 49H shows an alternate end point, in which the transvalvular bandis additionally provided with a transventricular truss and an epicardialanchor.

FIG. 50A is a side elevational schematic view of the distal end of adeployment catheter, having a rolled up transvalvular band therein.

FIG. 50B is an illustration as in FIG. 50A, following distal deploymentof the transvalvular band.

FIGS. 51A and 51B illustrate top plan views and side views of atransvalvular band in accordance with the present invention.

FIG. 51C illustrates a perspective view of one embodiment of atransvalvular band in a rolled-up configuration and mounted on adelivery mandrel.

FIG. 51D illustrates a view of at least a non-linear portion of a strutof FIG. 51B.

FIGS. 52A through 52C illustrate a transvalvular band, with a “t-tag”deployment system and suture tensioning feature.

FIG. 52D illustrates an embodiment of a plurality of tissue anchorslooped together on a suture.

FIG. 53 is a side elevational perspective view of a transvalvular bandin accordance with the present invention.

FIG. 54 is a schematic illustration of various suture lockconfigurations for use on transvalvular bands of the present invention.

FIG. 55 is a side elevational perspective view of a transvalvular band,having barbed tissue anchors thereon.

FIG. 56 is a side elevational perspective view of a transvalvular bandin accordance with the present invention, having arcuate tissue anchorsthereon.

FIGS. 56A-B are graphs illustrating data regarding chordal physiologicforce experiments.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

FIG. 1 illustrates a cross-sectional view of the heart 10 with a normalmitral valve 18 in systole. As illustrated, the heart 10 comprises theleft atrium 12 which receives oxygenated blood from the pulmonary veins14 and the left ventricle 16 which receives blood from the left atrium12. The mitral valve 18 is located between the left atrium 12 and leftventricle 16 and functions to regulate the flow of blood from the leftatrium 12 to the left ventricle 16. During ventricular diastole, themitral valve 18 is open which allows blood to fill the left ventricle16. During ventricular systole, the left ventricle 16 contracts, whichresults in an increase in pressure inside the left ventricle 16. Themitral valve 18 closes when the pressure inside the left ventricle 16increases above the pressure within the left atrium 12. The pressurewithin the left ventricle 16 continues increasing until the pressurewithin the left ventricle 16 exceeds the pressure within the aorta 20,which causes the aortic valve 22 to open and blood to be ejected fromthe left ventricle and into the aorta 20.

The mitral valve 18 comprises an anterior leaflet 24 and a posteriorleaflet 26 that have base portions that are attached to a fibrous ringcalled the mitral valve annulus 28. Each of the leaflets 24 and 26 hasrespective free edges 36 and 38. Attached to the ventricular side of theleaflets 24 and 26 are relatively inelastic chordae tendineae 30. Thechordae tendineae 30 are anchored to papillary muscles 32 that extendfrom the intraventricular septum 34. The chordae tendineae 30 andpapillary muscle 32 function to prevent the leaflets 24 and 26 fromprolapsing and enable proper coaptation of the leaflets 24 and 26 duringmitral valve 18 closure. Also shown schematically is line 9 through thevalve annulus 28 representing the intraannular plane. Arrow 8 pointssupraannularly, toward the left atrium 12, while arrow 7 pointsinfraannularly, toward the left ventricle 16.

FIG. 2 illustrates a cross-sectional view of the heart 10 with a normalmitral valve 18 in diastole. After the left ventricle 16 has ejected theblood into the aorta, the left ventricle relaxes, which results in adrop in pressure within the left ventricle 16. When the pressure in theleft ventricle 16 drops below the pressure in the aorta 20, the aorticvalve 22 closes. The pressure within the left ventricle 16 continuesdropping until the pressure in the left ventricle 16 is less than thepressure in the left atrium 12, at which point the mitral valve 18opens, as shown in FIG. 2. During the early filling phase, bloodpassively fills the left ventricle 16 and this accounts for most of thefilling of the left ventricle 16 in an individual at rest. At the end ofthe filling phase, the left atrium 12 contracts and provides a finalkick that ejects additional blood into the left ventricle. Also shown isintraannular plane 9 as described above, and line 6 representing thelongitudinal axis 6 of the valve 18.

FIG. 3 illustrates a bottom view of normal mitral valve 18 in systole,looking from the left atrium and to the left ventricle. As shown, theanterior leaflet 24 and posterior leaflet 26 are properly coapted,thereby forming a coaptive edge 40 that forms a seal that preventsretrograde flow of blood through the mitral valve 18, which is known asmitral regurgitation. FIG. 4 illustrates a bottom view of normal mitralvalve 18 in diastole. FIG. 5 provides a side cross-sectional view of anormal mitral valve 18 in systole. As shown in FIG. 5, the valveleaflets 24 and 26 do not normally cross the plane P defined by theannulus and the free edges 36 and 38 coapt together to form a coaptiveedge 40.

FIG. 5 also illustrates a coaption zone 41. Preferably the depth ofcoaption (length of zone 41 in the direction of blood flow, in which theleaflets 24 and 26 are in contact) is at least about 2 mm or 5 mm, andis preferably within the range of from about 7 mm to about 10 mm for themitral valve.

Thus, implantation of the devices in accordance with the presentinvention preferably achieves an increase in the depth of coaption. Atincrease of at least about 1 mm, preferably at least about 2 mm, and insome instances an increase of at least about 3 mm to 5 mm or more may beaccomplished.

In addition to improving coaption depth, implantation of devices inaccordance with the present invention preferably also increase the widthof coaptation along the coaption plane. This may be accomplished, forexample, by utilizing an implant having a widened portion for contactingthe leaflets in the area of coaption such as is illustrated inconnection with FIG. 19A and 19B below. A further modification of thecoaptive action of the leaflets which is accomplished in accordance withthe present invention is to achieve early coaption. This is accomplishedby the curvature or other elevation of the implant in the ventricledirection. This allows the present invention to achieve early coaptionrelative to the cardiac cycle, relative to the coaption point prior toimplantation of devices in accordance with the present invention.

FIGS. 4 and 6 illustrate normal mitral valve 18 in diastole. As shown,the anterior leaflet 24 and posterior leaflet 26 are in a fully openedconfiguration which allows blood to flow from the left atrium to theleft ventricle.

FIGS. 7 and 8 illustrate a heart 10 in systole where the anteriorleaflet 24 of the mitral valve 18 is in prolapse. Anterior leaflet 24prolapse can be caused by a variety of mechanisms. For example, asillustrated in FIG. 7, rupture 42 of a portion of the chordae tendineae30 attached to the anterior leaflet 24 can cause the free edge 36 of theanterior leaflet 24 to invert during mitral valve 18 closure. As shownin FIG. 8, inversion 44 of the anterior leaflet 24 can prevent themitral valve leaflets 24 and 26 from properly coapting and forming aseal. This situation where the free edge 36 of the anterior leaflet 24crosses into the left atrium 12 during mitral valve 18 closure can leadto mitral regurgitation.

Similarly, FIGS. 9 and 10 illustrate posterior leaflet 26 prolapsecaused by a rupture of the chordae tendineae 30 attached to theposterior leaflet 26. In this case, the posterior leaflet 26 can invertand cross into the left atrium 12 during mitral valve 18 closure. Theinversion of the posterior leaflet 26 prevents the mitral valve leaflets24 and 26 from properly coapting and forming a seal, which can lead tomitral regurgitation.

Mitral regurgitation can also be caused by an elongated valve leaflet 24and 26. For example, an elongated anterior leaflet 24, as shown in FIG.11, can prevent the valve leaflets 24 and 26 from properly coaptingduring mitral valve 18 closure. This can lead to excessive bulging ofthe anterior leaflet 24 into the left atrium 12 and misalignment of thefree edges 36 and 38 during coaptation, which can lead to mitralregurgitation.

One embodiment of a transvalvular band 50 that would improve mitralvalve leaflet 24 and 26 coaptation and prevent or reduce mitralregurgitation is illustrated in FIGS. 12 and 13. FIG. 12 provides a topview of the transvalvular band 50 while FIG. 13 provides a side view ofthe transvalvular band 50. In this embodiment, the transvalvular band 50comprises an elongate and curved structure with a first end 52, a secondend 54, a central portion 64 located between the two ends 52 and 54, anda length that is capable of extending across the annulus. The leafletcontact surface 56 is convex along the longitudinal axis, as bestillustrated in FIG. 13. In other embodiments, the leaflet contactsurface 56 can have a different shape and profile. For example, thecontact surface 56 can be concave, straight, a combination of convex,concave and/or straight, or two concave or straight portions joinedtogether at an apex. As illustrated in FIG. 12, the transvalvular band50 can have a substantially constant width between the first end 52 andthe second end 54. The first end 52 has a first anchoring portion 58 andthe second end 54 has a second anchoring portion 60.

The anchoring portions 58 and 60 can have holes 62 for sutures thatallow the transvalvular band 50 to be secured to the annulus.Alternatively, in other embodiments the anchoring portions 58 and 60 canhave other means for securing the transvalvular band 50 to the annulus.For example, the anchoring portions 58 and 60 can be made of a membraneor other fabric-like material such as Dacron or ePTFE. Sutures can bethreaded directly through the fabric without the need for distinct holes62. The fabric can be attached to the other portions of thetransvalvular band 50 by a variety of techniques. For example, thefabric can be attached to the other portions of the transvalvular band50 with the use of an adhesive, by suturing, by tying, by clamping or byfusing the parts together. Another non-limiting technique of securingthe transvalvular band to the annulus is to coat a malleable metal basismaterial, which creates structure for securing a skeleton of thetransvalvular band, with a polymer such as silicone and bonding amaterial, such as PET (i.e., Dacron) velour for comprehensive tissueingrowth when desired.

The central portion of the transvalvular band 50 can have a variety ofcross-sectional shapes, as illustrated in FIGS. 14-17. For example, thecross sectional shape can be substantially rectangular, circular, oblongor triangular. The edges of the transvalvular band 50 can be rounded orotherwise configured so that the transvalvular band 50 presents anatraumatic surface 51 to the valve leaflets. In some embodiments, thecross-section can be oriented in a particular fashion to enhanceperformance of the transvalvular band 50. For example as shown in FIG.14, a transvalvular band 50 with a triangular cross section can bedesigned so that a relatively larger surface 56 of the triangle contactsthe valve leaflets while a lower profile leading edge 53 of the triangleopposite the surface 51 faces the left atrium. This configuration allowsa larger surface area to make contact with and support the mitral valveleaflets, while also presenting a more streamlined shape that providesless resistance to blood flowing from the left atrium to the leftventricle. Decreasing the resistance to blood flow is desirable becauseit can reduce turbulence and reduce the impedance of the transvalvularband 50 on the filling of the left ventricle. Similarly, thetransvalvular bands 50 with an oblong or rectangular cross-section canbe oriented to either increase the surface area for contact with thevalve leaflets, or be oriented to reduce the resistance to blood flow.

The dimensions of the transvalvular band 50 will vary, depending uponthe specific configuration of the band 50 as well as the intendedpatient. In general, transvalvular band 50 will have an axial lengthfrom first end 52 to second end 54 within the range of from about 20 mmto about 32 mm. In one embodiment, intended for a typical male adult,the axial length of the transvalvular band 50 is about 24 mm to 26 mm.The width of the transvalvular band 50 in the central zone 64 may bevaried depending upon the desired performance, as will be discussedherein. In general, the trailing surface 51 against which leaflets willseat is preferably large enough to minimize the risk of erosionresulting from repeated contact between the closed leaflets and theimplant. The width of the leading edge 53 is preferably minimized, asdiscussed above, to minimize flow turbulence and flow obstruction. Ingeneral, widths of the surface 51 measured perpendicular to the flow ofblood are presently contemplated to be less than about 5 mm, and oftenwithin the range of from about 5 mm to about 10 mm in the zone ofcoaptation.

In some embodiments as illustrated in FIG. 18, the central portion 64 ofthe transvalvular band 50 can be narrower in width, measuredperpendicular to blood flow than the first and second anchoring portions58 and 60. By narrowing the central portion 64, the resistance to bloodflow can be reduced. However, narrowing the central portion 64 reducesthe surface area of the leaflet contact surface 56 that supports thevalve leaflets.

In the embodiment illustrated in FIG. 18, the narrowed central portion64 is separated from the first anchoring portion 58 and second anchoringportion 60 by a first shoulder 57 and second shoulder 59. The length ofthe central portion 64, between first shoulder 57 and second shoulder 59can be less than about 50% of the overall length of the device, or lessthan about 30% of the overall length of the device if it is desired tominimize the obstruction in the center of the flow path, whilepresenting a wider transverse surface for supporting the leaflets whenthe valve is closed. Alternatively, the length of the central zone 64may be greater than 50%, and in some embodiments greater than 75% of theoverall length of the implant.

In some embodiments as illustrated in FIGS. 19A, 19B, 21 and 23, acoaptive edge support portion 66 of the central portion 64 of thetransvalvular band 50 can be wider than the adjacent portions of thetransvalvular band 50, leading up to and potentially including the firstand second anchoring portions 58 and 60. By increasing the width andsurface area of the coaptive edge support portion 66, more support canbe provided to the valve leaflets at the coaptive edge. This increasedsupport can increase the width of leaflet coaption. The other portionsof the central portion 64 can remain narrow to reduce the resistance toblood flow. The support portion 66 can be located at a fixed position oradjustable along the transvalvular band so that its position can beoptimized by the surgeon and then secured at a fixed point such as bysuturing, or removed if deemed unnecessary.

In one implementation of the invention, the transvalvular band comprisesa first component for primary reduction and a second component for fineadjustment. For example, the device illustrated in FIG. 19A may beprovided with an adjustable (e.g. slidable) support portion 66. Thetransvalvular band may be positioned across the annulus as has beendescribed herein, and hemodynamic function of the valve may beevaluated. The support portion 66 may thereafter be adjusted along thelength of the transvalvular band to treat residual leakage or otherwiseoptimize the functionality of the implant such as by increasing the zoneof coaptation. The second component (e.g. support portion 66) maythereafter be fixed with respect to the transvalvular band such as bysutures, clips, adhesives, or other techniques known in the art.Alternatively, the second portion may be separate from and connectableto the transvalvular band such as stitching, clips, suturing or othertechnique known in the art.

In addition, the coaptive edge support portion 66 can be offset from thecenter of the transvalvular band 50, to reflect the asymmetry betweenthe anterior leaflet and the posterior leaflet. For example, thecoaptive edge support portion 66 can be positioned closer to the firstanchoring portion 58 than to the second anchoring portion 60. In certainembodiments, the edge support portion 66 will be centered about a pointwhich is within the range of from about 20% to about 45% of the overalllength of the implant from the closest end.

FIG. 20 illustrates another embodiment of a transvalvular band 50 thatis a modification of the transvalvular band 50 shown in FIG. 18. Asillustrated in FIG. 20, the transvalvular band 50 has a narrow centralportion 64 that provides relatively low resistance to blood flow.However, the first and second anchoring portions 58 and 60 extendfurther in a lateral direction, and can be arcuate to conform to themitral valve annulus. These laterally extended anchoring portions 58 and60 provide additional anchoring of the transvalvular band 50 and canhelp improve the stability of the device after implantation. Thelaterally extending anchoring portion 58 and 60 may be provided with anyof a variety of structures for facilitating anchoring to the valveannulus. For example, they may be provided with a plurality of apertures61, for conventional stitching or to receive any of a variety of clipsor tissue anchors. The anchoring portions may alternatively be providedwith any of a variety of barbs or hooks, or may be provided with afabric covering such as a Dacron sleeve to facilitate sewing. Further,in some embodiments, this sewing ring may have an elastomeric core uponwhich the Dacron is secured to provide a more compliant structure tohold the implant. Measured in the circumferential direction (transverseto the longitudinal axis of the implant 50) the laterally extendinganchoring portions will have an arc length of greater than about 5 mm,and, in some embodiments, greater than about 1 cm. Arc lengths of atleast about 2 cm, and, in some embodiments, at least about 3 cm may beutilized, depending upon the desired clinical performance.

FIG. 21 illustrates another embodiment of a transvalvular band 50 withthe extended anchoring portions 58 and 60 and a wider, offset coaptiveedge support portion 66. This embodiment has the benefit of additionalstability provided by the extended anchoring portions 58 and 60 andenhanced support of the coaptive edge.

FIGS. 22 and 23 illustrate another embodiment of a transvalvular band 50which is combined with an annular ring 68. The annular ring 68 can beused as both a support for the transvalvular band 50 and, if desired,also to help stabilize the size and shape of the mitral valve annulusitself. In some embodiments, the annular ring 68 can be used to reducethe size of the mitral valve annulus and to bring the mitral valveleaflets closer together. This can be accomplished by, for example,suturing the mitral valve annulus to an annular ring 68 of smallerdiameter. In addition, the annular ring 68 provides additional supportand stability to the transvalvular band 50. The anchoring portions 58and 60 of the transvalvular band 50 can be formed integrally with theannular ring 68, or the anchoring portions 58 and 60 can be attached tothe annular ring by a variety of means, such as suturing, bonding,adhesives, stapling and fusing. FIG. 22 discloses an embodiment with anarrow central portion 64 while FIG. 23 discloses an embodiment with awider, offset coaptive edge support portion 66.

FIG. 23A illustrates a further implementation of the invention, adaptedto treat ischemic mitral regurgitation with posterior annuloplasty. Atransvalvular band 61 is provided for spanning the leaflet coaptionplane as has been described herein. Any of the features described inconnection with other transvalvular bands disclosed herein may beincorporated into the transvalvular band 61.

An arcuate posterior annuloplasty support 63 is connected to thetransvalvular band 61, and adapted to extend for an arc length along thenative annulus. In the illustrated embodiment, the support 63 extendsthrough an arc of approximately 180°, extending from a first trigoneattachment zone 65 to a second trigone attachment zone 67. Theattachment zones may be provided with sewing apertures, a fabriccovering, or other structure for facilitating attachment to tissue. Ingeneral, the transvalvular band 61 will have dimensions similar to thosedescribed elsewhere herein. The transverse dimension from first trigonezone 65 to second trigone zone 67 may be varied depending upon the sizeof the native annulus, but will generally be within the range of fromabout 35 mm to about 45 mm.

Referring to FIG. 23B, there is illustrated a transvalvular band inaccordance with the present invention, formed from a single length orseveral lengths of flexible wire. The bend angles and orientation of thestruts in the illustrated embodiment may be readily altered, toaccommodate the desired axes of compression which may be desirable for aparticular deployment procedure.

In general, the transvalvular band 71 comprises an elongate flexiblewire 73 formed into a serpentine pattern, for providing a support forthe valve leaflets as has been discussed herein. Although notillustrated in FIG. 23B, the wire 73 may be formed such that it bows orinclines in the direction of the ventricle to achieve early closure asis discussed elsewhere herein. The wire 73 may extend into a firstconnection section 75 and a second connection section 77. Each of theconnection sections 75 and 77 may be provided with a plurality ofeyelets 79, to receive sutures for attaching the implant to the valveannulus. The implant may be formed from any of a variety of flexiblematerials, including various polymers described elsewhere herein as wellas titanium, titanium alloy, Nitinol, stainless steel, elgiloy, MP35N,or other metals known in the art. This design has an advantage ofproviding a relatively large support footprint against the valveleaflets, while at the same time optimizing the area of open space topermit maximum blood flow therethrough. The design may be treated orcoated with silicone or other suitable material to eliminate untowardeffects such as thrombosis or corrosion. Treatments may be sequentialand include more than one listed but not limited to electropolishing,harperization, tumbling, pickling, plating, encapsulation or physicalvapor deposition of appropriate materials.

FIGS. 24-27 illustrate side views of transvalvular bands 50 withdifferent inclinations. One of the objectives of the present inventionis to not merely provide support to the leaflets during systole, but toelevate the plane of coaption in the direction of the ventricle, tocause early coaption (closure) relative to the cardiac cycle, as isdiscussed elsewhere herein. The variation in conditions, and otherpatient to patient variations may warrant production of thetransvalvular band of the present invention in an array of sizes and/orconfigurations, so that clinical judgment may be exercised to select theappropriate implant for a given case. Alternatively, the transvalvularband may be provided in an adjustable form or a modular form so that animplant of the desired configuration can be constructed or modifiedintraoperatively at the clinical site. In a three segment embodiment,such as that illustrated in FIGS. 24 through 27, a central segment maybe provided for positioning within the center of the flow path, orcentered on the coaptive edges of the leaflets. First and second endportions may be connected to the central portion, for supporting thecentral portion relative to the tissue anchors. First and second endportions may be provided in a variety of lengths and curvatures,enabling construction of a relatively customized modular implant as maybe desired for a particular patient.

For example, FIG. 24 illustrates a transvalvular band 50 with a centralportion 64 and two gently angled arm portions 70 and 72. The first andsecond ends 52 and 54 are displaced from the central portion 64 by aheight, h1 and h2, respectively. In FIG. 24, h1 and h2 are about equaland can range from about 0 mm to about 10 mm. Preferably h1 and h2 willbe at least about 2 mm and will often be at least about 4 mm or 6 mm ormore, but generally no more than about 10 mm or 12 mm.

FIG. 25 illustrates a transvalvular band 50 with a central portion 64and two sharply angled arm portions 70 and 72. The first and second ends52 and 54 are displaced from the central portion 64 by a height, h1 andh2, respectively. In FIG. 25, h1 and h2 are about equal and can rangefrom about 8 mm to about 12 mm. FIG. 26 illustrates a transvalvular band50 with a central portion 64, a highly angled first arm 70 and a gentlyangled second arm 72. The first and second ends 52 and 54 are displacedfrom the central portion 64 by a height, h1 and h2, respectively. InFIG. 26, h1 is greater than h2. The h1 ranges from about 6 mm to about10 mm, while h2 ranges from about 2 mm to about 6 mm. FIG. 27illustrates a transvalvular band 50 with a central portion 64, a gentlyangled first arm 70 and a highly angled second arm 72. The first andsecond ends 52 and 54 are displaced from the central portion 64 by aheight, h1 and h2, respectively. FIG. 27, may be a mirror image of FIG.26.

The transvalvular band 50 can be made of any of a variety of materialsthat are compatible with implantation within a patient's body and whichhas the requisite structural integrity to support the mitral valveleaflets. For example, suitable materials include titanium, titaniumalloys, stainless steel, stainless steel alloys, nitinol, elgiloy,MP35N, other metals and alloys, ceramics, and polymers such as PTFE,polycarbonate, polypropylene, UHMWPE, HDPE, PEEK, PEBAX and the like.

In order to reduce the thrombogenicity of the transvalvular band 50, thetransvalvular band 50 can be provided with a smooth surface orappropriately micro-texture the surface in some embodiments, such as viaa porous or microporous structure. Other factors such as surfacechemistry, energy, morphology, macrofeatures, and general materialproperties matching the in situ needs can also be considered intailoring the surface of the band. In addition, the transvalvular band50 can be coated with a variety of substances to reduce thrombogenicity.For example, the transvalvular band 50 can be coated with aantithrombogenic agent such as heparin, a polymer such as PTFE, or apolymer conjugated with heparin or another antithrombogenic agent.Heparin coatings can be achieved in a variety of methods, one of whichmay be to coat or drip the prosthesis in TDMAC-heparin(Tridodecylmethylammonium heparinate).

As illustrated in FIGS. 28-31, the transvalvular band 50 is implanted inthe plane of the mitral valve annulus 28 in a patient suffering fromanterior leaflet 26 prolapse caused by the rupture 42 of the chordaetendineae 30 attached to the anterior leaflet 26. Although a prolapsedanterior leaflet 26 is illustrated, it should be understood that themethod described herein is also applicable for treating other types ofprolapse, such as posterior leaflet prolapse and prolapse caused byelongated leaflets 24 and 26. The transvalvular band 50 can be attachedto the annulus 28 by a variety of techniques, such as sutures, anchors,barbs, stapes, self-expanding stents, or other techniques that are knownor are apparent to those of skill in the art.

As best illustrated in FIGS. 29 and 31, the transvalvular band 50 isoriented in the annulus 28 so that the transvalvular band 50 ispositioned approximately transversely to the coaptive edge 42 formed bythe closure of the mitral valve leaflets 24 and 26. The transvalvularband 50 can also be positioned over the prolapsed portion of theanterior leaflet 26 so that the transvalvular band 50 can directlysupport the prolapsed portion of the anterior leaflet 24 and keep theanterior leaflet 24 inferior to the plane of the mitral valve annulus28, i.e., elevated in the direction of the ventricle or of antegradeflow, thereby preventing or reducing prolapse and mitral regurgitation.

FIGS. 28 and 29 illustrate the effect of the transvalvular band 50 onthe mitral valve 18 during systole. As shown, both the anterior leaflet24 and the posterior leaflet 26 are supported by the transvalvular bandduring closure of the mitral valve 18. The arcuate transvalvular band 50functions to keep both leaflets 24 and 26 inferior to the plane of theannulus 28 and enables the leaflets 24 and 26 to form a coaptive edge40. Although a single transvalvular band 50 has been illustrated, insome embodiments, multiple transvalvular bands 50 such as two or threeor more can be implanted across the annulus 28 to provide additionalsupport to the mitral valve leaflets 24 and 26.

FIGS. 30 and 31 illustrate the effect of the transvalvular band 50 onthe mitral valve 18 during diastole. During diastole, the mitral valve18 opens so that blood can fill the left ventricle 16 from the leftatrium 12. As best illustrated in FIG. 31, the transvalvular band 50obstructs only a small portion of the mitral valve 18 opening, andtherefore, does not cause excessive resistance to blood flow.

FIGS. 32-35 are cross-sectional side views of the mitral valve 18 withand without the support of the transvalvular band 50. During systole,the mitral valve 18 closes. Without the transvalvular band 50, theanterior leaflet 24 crosses the plane P defined by the mitral valveannulus 28 and prolapse, which leads to mitral regurgitation, as shownin FIG. 33. However, by implanting the transvalvular band 50 in theannulus 28 such that the arcuate transvalvular band 50 arches towardsthe left ventricle and the central portion 64 is displaced from theplane P, the anterior leaflet 24 is prevented from prolapsing above theplane P thus eliminating or reducing retrograde flow (shown in FIG. 33).The leaflets 24 and 26 rest upon the transvalvular band 50 and thepressure exerted by the blood upon the distal portion of the leaflets 24and 26 form the coaptive edge 40. As illustrated in FIGS. 34 and 35, theperformance of the mitral valve 18 during diastole is not substantiallyaffected by the transvalvular band 50.

Although the method of implanting and positioning the transvalvular band50 has been illustrated with one embodiment of the transvalvular band50, other embodiments as described above can also be used. For example,FIG. 36 illustrates a transvalvular band 50 with a wider, offsetcoaptive edge support portion 66 that has been implanted in the mitralvalve annulus. As shown, the coaptive edge support 66 is offset so thatit positioned to support the coaptive edge of the mitral valve 18. Inaddition, the transvalvular band 50 can be used in conjunction withother devices and procedures, such as a separate or integrally attachedannular or annuloplasty ring described above. In addition, thetransvalvular band 50 can be used in conjunction with the Alfieriprocedure, where the tips of the mitral valve leaflets 24 and 26 aresutured 74 together, as shown in FIG. 38.

Referring to FIG. 37, there is illustrated a perspective view of atransvalvular band 50 having a transverse projection or support 51extending in the direction of the ventricle or in the direction ofdiastolic blood flow, which could be considered antegrade. The support51 has a width W, which may be at least about 3 mm, and in someembodiments, at least about 5 mm, and in other embodiments at leastabout 1.0 cm. The projection 51 may be utilized without an Alfieristitch, so that the leaflets of the mitral valve close against opposingside walls 53 and 55 of the projection 51. The projection 51 thus helpscenter the closure of the leaflets, as well as controlling the width ofcoaption. In addition, the band 50 is illustrated as convex in thedirection of the ventricle, to accomplish early closure as has beendiscussed herein.

The transvalvular band in accordance with the present invention can beimplanted via an open surgical procedure, via thoracotomy (e.g.transapically) or alternatively, via a percutaneous procedure using atranslumenally implantable embodiment. In the translumenally implantableembodiment, one or more transvalvular bands can be attached to aself-expandable support structure, such as a self-expandable ring orself-expandable stent having a relatively short axial length relative toits expanded diameter. The transvalvular band and the compressedself-expandable support structure are loaded into a catheter with aretractable outer sheath which is inserted percutaneously and advancedtranslumenally into or across the mitral valve. The retractable outersheath can be retracted to allow the self-expandable support structureto expand adjacent or against the annulus, thereby positioning the oneor more transvalvular bands in about the plane of the mitral annulus.Each transvalvular band can be characterized by a longitudinal axis, andthe transvalvular band is oriented in the mitral valve such that thelongitudinal axis of the transvalvular band in oriented substantiallytransversely to the coaptive edge of the mitral valve.

By “percutaneous” it is meant that a location of the vasculature remotefrom the heart is accessed through the skin, such as using needle accessthrough, for example, the Seldinger technique. However, it may alsoinclude using a surgical cut down procedure or a minimally invasiveprocedure. The ability to percutaneously access the remote vasculatureis well-known and described in the patent and medical literature.

Depending on the point of vascular access, the approach to the mitralvalve may be antegrade and require entry into the left atrium via thepulmonary vein or by crossing the interatrial septum. Alternatively,approach to the mitral valve can be retrograde where the left ventricleis entered through the aortic valve. Once percutaneous access isachieved, the interventional tools and supporting catheter(s) will beadvanced to the heart intravascularly where they may be positionedadjacent the target cardiac valve in a variety of manners, as describedelsewhere herein. While the methods will preferably be percutaneous andintravascular, many of the implants and catheters described herein will,of course, also be useful for performing open surgical techniques wherethe heart is beating or stopped and the heart valve accessed through themyocardial tissue. Many of the devices will also find use in minimallyinvasive procedures where access is achieved thorascopically and wherethe heart will usually be stopped but in some instances could remainbeating.

A typical antegrade approach to the mitral valve is depicted in FIG. 39.The mitral valve MV may be accessed by a standard approach from theinferior vena cava IVC or superior vena cava SVC, through the rightatrium RA, across the interatrial septum IAS and into the left atrium LAabove the mitral valve MV. As shown, a catheter 120 having a needle 122may be advanced from the inferior vena cava IVC into the right atriumRA. Once the catheter 120 reaches the interatrial septum IAS, the needle122 may be advanced so that it penetrates through the septum at thefossa ovalis FO or the foramen ovale into the left atrium LA. At thispoint, a guidewire may be advanced out of the needle 122 and thecatheter 120 withdrawn.

As shown in FIG. 40, access through the interatrial septum IAS willusually be maintained by the placement of a guide catheter 125,typically over a guidewire 124 which has been placed as described above.The guide catheter 125 affords subsequent access to permit introductionof the tool(s) which will be used for performing the valve or tissuemodification, as described in more detail below.

A typical retrograde approach to the mitral valve is depicted in FIG.41. Here the mitral valve MV may be accessed by an approach from theaortic arch AA, across the aortic valve AV, and into the left ventriclebelow the mitral valve MV. The aortic arch AA may be accessed through aconventional femoral artery access route, as well as through more directapproaches via the brachial artery, axillary artery, or a radial orcarotid artery. As shown in FIG. 42, such access may be achieved withthe use of a guidewire 128. Once in place, a guide catheter 126 may betracked over the guidewire 128. The guide catheter 126 affordssubsequent access to permit introduction of the tool(s) which will beused for performing the valve modification, as described in more detailbelow.

In some cases, access routes to the mitral valve may be established inboth antegrade and retrograde approach directions. This may be usefulwhen, for instance, grasping is performed with the use of specificdevices introduced through one route and fixation is achieved with theuse of separate devices introduced through another route. In onepossible situation, the transvalvular band may be introduced via aretrograde approach. While the transvalvular band is held in place, afixation tool may be introduced via an antegrade approach to fix thetransvalvular band in place. The access pathways for the transvalvularband and fixation tool may alternatively be reversed. Thus, a variety ofaccess routes may be used individually or in combination with themethods and devices of the present invention.

Referring to FIG. 43A, there is illustrated a schematic view of apercutaneously deliverable implant in accordance with one aspect of thepresent invention. The deployment system includes a deployment catheter200, only a distal end of which is illustrated herein. Deploymentcatheter 200 is configured in accordance with known technology foraccessing the mitral valve, utilizing conventional dimensions and thematerials known to those of skill in the art. In general, the deploymentcatheter 200 comprises an elongate flexible tubular body 202 extendingbetween a proximal end (not illustrated) and a distal end 204. Theproximal end is provided with a proximal manifold, including accessportals such as luer connectors in communication with each functionallumen in the catheter 200.

The distal end 204 is provided with a distally facing opening 208, whichis in communication with the proximal end via a central lumen 206.

Positioned within the central lumen 206 is a collapsed implant 210.Implant 210 is transformable between a first, radially reducedconfiguration such as for positioning within the deployment catheter 200and a second, radially enlarged configuration (see FIG. 43C) forpositioning at the treatment site. Transformation of the implant fromthe first configuration to the second configuration may be accomplishedunder positive force, such as via balloon dilatation. Alternatively, asillustrated herein, transformation is accomplished by self-expansion ofthe implant 210 in response to removal of the constraint provided by thetubular body 202.

In general, the implant 210 comprises a frame or anchor component 212and a leaflet support component 214. Leaflet support component 214 maycomprise any of a variety of structures similar to those describedpreviously herein as the annular band, configured or reconfigured suchthat the annular band may be radially reduced for positioning within adeployment catheter and subsequently radially enlarged for spanning themitral valve. The implant 210 additionally comprises an anchorcomponent, for anchoring the leaflet support 214 at the treatment site.In the illustrated embodiment, anchor 212 is schematically illustratedas a zigzag wire or filament structure, which is radially expansiblefollowing removal of the constraint. However, any of a variety ofconfigurations may be utilized for the anchor 212.

Referring to FIG. 43B, the outer tubular flexible body 202 is shownpartially retracted from the implant, permitting the implant to begin toradially expand. FIG. 43C illustrates further retraction of the tubularbody 202, to fully release the anchor 212 at the deployment site. Asillustrated, anchor 212 radially expands within the left atrium. Theleaflet support 214 extends approximately transversely to the coaptiveedge of the mitral valve leaflets, and is convex or inclined in thedirection of the mitral valve to advance the coaptation of the mitralvalve leaflets in the direction of the ventricle as has been describedelsewhere herein.

As seen in FIG. 43A, the implant 210 is controlled by at least onecontrol line 216. Control line 216 extends throughout the length of thedeployment catheter 200, and to at least one control on or near theproximal manifold. This enables proximal retraction of the flexible body202 with respect to the implant 210, and control of implant 210 prior tofinal detachment from the deployment system.

Referring to FIG. 43C, at least a first control wire 216, a secondcontrol wire 218, and a third control wire 220 are illustrated connectedto the anchor 212. Control wires 216, 218 and 220 enable manipulation ofthe implant into its final desired position, and, if necessary, proximalretraction of the implant back within the deployment catheter should thedecision be made to remove the implant prior to final detachment.

Prior to final detachment of the implant 210, additional anchoringstructures may be engaged to retain the implant at its desired implantedlocation. For example, anchor 212 may be provided with any of a varietyof tissue anchors or barbs, for engaging the mitral valve annulus or thebase of the leaflets or other adjacent anatomical structures.Alternatively, separate tissue anchors may be advanced through thedeployment catheter 200, and utilized to secure the anchor 212 to theadjacent tissue. Suitable anchors are preferably enlargeable from afirst, reduced cross sectional configuration for traveling through thedeployment catheter 200 and piercing tissue, to a second, enlargedconfiguration for resisting removal from the tissue. In the embodimentillustrated in FIG. 43C, no secondary anchoring structures areillustrated for simplicity.

Once the position of the implant 210 has been verified and foundacceptable, and the determination of whether to introduce secondaryanchoring structures has been made, the control wires 216, 218 and 220are detached from the anchor 212, and the deployment catheter 200 isremoved from the patient. Detachment of the control wires from theimplant 210 may be accomplished in any of a variety of ways, such as byelectrolytic detachment, detachment by thermal elevation of a softenableor meltable link, mechanical detachment such as by rotating the controlwire such that a threaded end of the control wire is threadablydisengaged from the anchor 212, or other detachment techniques dependingupon the desired functionality and profile of the system.

Referring to FIG. 43D, there is illustrated a side elevational view ofthe implant 210 in an unconstrained (e.g., bench top) expandedconfiguration. The anchor 210 comprises a plurality of struts 222, whichare joined at a first end by a plurality of apices 224 and a second endby a plurality of apices 226 to produce a zigzag structure sometimesreferred to as a “Z stent” configuration. This configuration isconvenient and well understood in the intravascular implant arts,although any wide variety of structures may be utilized. For example,zigzag wire patterns, woven wire patterns, or sinusoidal wire patternsmay be utilized. Laser cut wall patterns such as from tubing stock mayalso be utilized, and may be provided with any of a wide variety ofcomplex wall patterns. In general, nickel titanium alloys such as any ofa variety of nitinol alloys are preferred. However, depending upon thewall pattern, stainless steel, elgiloy, certain polymers or othermaterials may also be utilized. Heat treatment may be required to annealand shape set an alloy such as Nitinol. Other alloys may require onlyannealing to relieve stresses incurred during prior processing.

Referring to FIG. 43E, there is illustrated an end view of the implantshown in FIG. 43D to show the transverse configuration of thetransvalvular band portion of the implant. In this illustration, thetransvalvular band comprises a plurality of struts 230 which areconnected to the anchor 212 at junctions 232. Struts 230 may in turn bedivided into a bifurcated section 234 or other configuration to increasethe effective footprint of the transvalvular band measured along thecoaptive edge of the valve, while minimizing obstruction to blood flowtherethrough. The coaptive edge of the valve, as implanted, willpreferably be approximately aligned with the transverse axis 236illustrated in FIG. 43E of the band, as implanted. The axis of coaptionof the mitral valve is preferably parallel to axis 236 in the implantedconfiguration, but may be within about 45°, preferably within about 20°,and most preferably within about 10° of the axis 236.

Referring to FIGS. 44A and 44B, there is illustrated an anchordeployment catheter which may be utilized to provide either primary orsecondary anchoring of the anchor structure 212 to adjacent tissue.Anchor deployment catheter 250 comprises an elongate flexible tubularbody 252, configured to access the vicinity of the mitral valve. Tubularbody 252 extends between a proximal end 254 and a distal end 256. Distalend 256 is provided with a distal opening 258, enabling access to acentral lumen 260. An elongate flexible core wire 262 extends from theproximal end 254 throughout most of the length of the lumen 260 to adistal surface 264. See FIG. 44C. The proximal end of the core wire 262is provided with a control 266 that enables axial reciprocal movement ofthe core wire 262 within the central lumen 260.

A tissue anchor 268 may be positioned within the distal end of thedelivery catheter 250. In use, manipulation of the control 266, such asby distal axial advance relative to the tubular body 252, distally,axially advances the core wire 262 to expel the anchor 268 through thedistal opening 258. Distal opening 258 is preferably provided with abevel or angled cut to provide a sharpened distal tip 270. This enablesdistal axial advance of the distal tip 270 into tissue at a desiredsite, so that the control 266 may be manipulated to deploy all or aportion of the anchor 268 into the target tissue.

Any of a variety of tissue anchors 268 may be utilized, depending uponthe desired configuration of the implant and the implant anchorinterface. In the illustrated embodiment, the anchor 268 is configuredas a double “t-tag” anchor. A first tissue engaging element 272 isconnected to a second implant engaging element 274 by a filament 276. Inuse, the distal tip 270 is positioned within the tissue of the mitralvalve annulus. Control 266 is manipulated to deploy the first element272 beneath the surface of the tissue. The tubular body 252 isthereafter proximally retracted, enabling the second element 274 toengage the implant and retain it against the adjacent tissue.

The anchor delivery catheter 250 may be advanced through the deploymentcatheter 200, and/or along a guide such as a guidewire or support wire.In the illustrated embodiment, the anchor deployment catheter 250 isprovided with a guide lumen 278 allowing the anchor delivery catheter totrack along a guidewire. Guide lumen 278 is defined by a tubular wall280. Tubular wall 280 may extend the entire length of the anchordelivery catheter 250, such as by forming the catheter body as a duallumen extrusion. Alternatively, tubular wall 280 may be provided with anaxial length that is short relative to the overall length of thecatheter, such as no more than about 3 cm and preferably no more thanabout 2 cm in length. This allows the anchor delivery catheter to ridealong a guidewire in a monorail or rapid exchange manner as will beillustrated below.

Referring to FIGS. 45A and 45B, there is illustrated an implantconfigured for use with the anchor delivery catheter described above. Ingeneral, the implant comprises a first leaflet support 292 and a secondleaflet support 294, separated by a flexible connection 296. Flexibleconnection 296 permits the implant 290 to be folded within a deploymentcatheter, and later expanded in a manner that permits the implant 290 tofunction as a transvalvular band as described. The implant 290 may bemanufactured in any of a variety of ways, such as using a wire frame orby laser cutting from sheet stock as will be appreciated by those ofskill in the art.

In the illustrated embodiment, a first and second flexible connection296 reside in a plane configured to be substantially parallel to theaxis of coaption the as implanted orientation. The lateral edges of theeach of the first leaflet support 292 and second leaflet support 294 areprovided with at least one and preferably two or three eyes 298, fabricpatches, or other anchor attachment structure, for receiving a tissueanchor.

Referring to FIG. 45B, the implant of FIG. 45A is illustrated in apartially collapsed configuration, flexed about the flexible connection296. In addition, control wires 300, 302 and 304 are illustratedreleasably connected to the implant 290. Control wires 300, 302 and 304may be utilized to advance the implant 290 from the deployment cathetersuch as catheter 200 described above, and manipulate the implant untilthe anchors have been fully deployed. Thereafter, control wires 300, 302and 304 may be removed such as by electrolytic detachment, melting apolymeric link, unscrewing a threaded connection, or other detachmentmechanism depending upon the desired functionality of the device.

Referring to FIGS. 46A through 46E, there is illustrated a sequence ofdeploying an implant at the mitral valve from an antegrade direction.The implant 290 may be similar to that illustrated in FIGS. 45A and 45B,or have wall patterns or characteristics of other implants disclosedelsewhere herein. In general, the implant 290 is deployed from thecatheter 200 in the sequence illustrated in FIGS. 46A through 46C. Thesurrounding anatomy has been eliminated for simplicity.

Referring to FIG. 46D, the anchor delivery catheter 250 is advanced ontothe proximal end of one of the control wires 300, such that the controlwire 300 is axially moveably positioned within guide lumen 278. Thisenables the anchor delivery catheter 250 to be advanced along thecontrol wire 300 in a monorail or rapid exchange configuration as isunderstood in the catheter arts. Anchor delivery catheter 250 isadvanced along the control wire 300 until the distal tip 270 advancesthrough the eye 298 or fabric tab or other attachment structure, andinto the adjacent tissue of the base of the mitral valve leaflet ormitral valve annulus. The control 266 is manipulated such as by distaladvance to advance the first anchor element 272 out of the distalopening 258 and into the tissue as illustrated in FIG. 46D.

The anchor delivery catheter 250 is thereafter proximally withdrawn toposition the distal opening 258 on the device proximal side of the eye298, and the core wire 262 is further distally advanced to deploy thesecond anchor element 274 from the distal opening 258 of the anchordelivery catheter 250. Anchor delivery catheter 250 may thereafter beproximally withdrawn from the patient. Either the same or a differentanchor delivery catheter 250 may thereafter be advanced along the thirdcontrol wire 304, enabling deployment of another tissue anchor as isillustrated in FIG. 46E.

The implant 290 is illustrated in FIG. 46E as having a central portioninclined in the direction of the ventricle to support the leaflets ashas been discussed elsewhere herein. This configuration may be retainedby the inherent bias built into the structure and materials of theimplant 290. Alternatively, the configuration of inclining in thedirection of the ventricle may be retained by active intervention suchas by providing a mechanical interlock, in situ heat weld withcapacitive discharge/electrolytic weld, application of a clip or otherlocking structure by way of control wire 302 or simply by the mechanicalforces attributable to the mitral valve annulus, which prohibit lateralexpansion of the device sufficient for the flexible connection 296 toinvert in the direction of the atrium. Alternatively, an implantablecontrol wire (not illustrated) may be introduced, to connect the implant290 such as in the vicinity of the flexible connection 296 to theopposing wall of the ventricle, as will be described in connection witha transapical implementation of the invention described below.

A further implementation of the invention is illustrated in connectionwith FIGS. 47A through 47E. Referring to FIG. 47A, the first controlline 300 and third control line 304 have been replaced by a first guidetube 310 and a second guide tube 312. First guide tube 310 and secondguide tube 312 each has the double function of controlling deployment ofthe implant, as well as enabling introduction of a tissue anchortherethrough. This avoids the use of a separate tissue anchor deploymentcatheter such as that described above.

As illustrated in FIG. 47B, once the implant is provisionally positionedin the vicinity of the mitral valve, a first tissue anchor 314 isdeployed through the first guide tube 310. A second tissue anchor 316 isdeployed through the second guide tube 312. The tissue anchors maycomprise “T” tag type constructions, pigtail or corkscrew constructions,or any of a variety of other soft tissue anchors known in the art. Ingeneral, tissue anchors utilized for the present purpose are preferablytransformable from a first, reduced cross-sectional configuration to asecond, radially enlarged cross-sectional configuration to enabledeployment through a small needle or tube and then provide a relativelyhigher resistance to pull out. Radial enlargement may be accomplished byangular movement of a portion of the anchor, or by physical expansion ina radial direction.

Referring to FIG. 47C, the first guide tube 310 and second guide tube312 have been removed following deployment of the tissue anchors. Theguide tubes may be removed using any of a variety of detachmenttechniques disclosed elsewhere herein. Either before or after removal ofthe guide tubes, distal pressure on either the tubular body 202 or thecontrol wire 302 inverts the implant from the configuration shown inFIG. 47C to the final configuration shown in FIG. 47D and E. Theinverted configuration of FIG. 47D and E may be retained by themechanical bias imparted through the anchoring to the mitral valveannulus, or using techniques described elsewhere herein. The controlwire 300 is thereafter detached from the implant, as illustrated in FIG.47E.

Any of a variety of the implants of the present invention mayalternatively be introduced across the ventricle, such as in atransapical approach. The retrograde approach to the mitral valve willnecessitate certain modifications to both the implant and the deploymentsystem, as will be appreciated by those of skill in the art in view ofthe disclosure herein.

For example, a transventricle approach is illustrated in FIGS. 48Athrough 48D. A deployment catheter 320 is introduced into the ventricle,and retrograde through the mitral valve to position the distal opening208 within the atrium. An implant is carried within the deploymentcatheter 320, as has been described elsewhere herein. In general, theimplant comprises a first leaflet support 292 and a second leafletsupport 294 separated by a flexible zone or pivot point.

In the retrograde implementation of the invention, the first and secondleaflet supports are flexible or pivotable with respect to thelongitudinal axis of the control wire 300, such that they may be movedbetween a first configuration in which there are substantially parallelwith the axis of the control wire 300, and a second position, asillustrated in FIGS. 48A through 48D, in which they are inclinedradially outwardly from the longitudinal axis of the control wire 300 inthe device proximal direction. The implant may thus reside within thedeployment catheter 320 when the first leaflet support 292 and secondleaflet support 294 are in the first, reduced crossing profileconfiguration, with each of the tissue anchors 314 and 316 pointing in adevice proximal direction. In this embodiment, the tissue anchor 314 maybe permanently affixed to or integral with the first leaflet support 292and the second anchor 316 may be similarly carried by the second leafletsupport 294.

Once the distal end of the deployment catheter 320 has been positionedwithin the atrium, the control wire 300 may be distally advanced toadvance the anchors 314 and 316 beyond the distal opening 208. Thisreleases the implant and allows the angle between the first and secondleaflet supports to be increased, so that the tissue anchors 314 and 316may be aimed at the desired tissue anchor target sites. Proximalretraction on the control wire 300 may be utilized to seat the tissueanchors within the target tissue, as illustrated in FIG. 48B.

Further proximal traction on the control wire 300 may be utilized toinvert the implant into the configuration illustrated in FIG. 48C. Atthat point, the control wire 300 may be severed from the implant as hasbeen discussed elsewhere herein. Alternatively, the deployment catheter320 may be proximally retracted leaving the control wire 300 secured tothe implant, and a second portion of the control wire may be secured toa tissue anchor 322 within or on the epicardial surface of theventricle. Anchor 322 may comprise any of a variety of structures, suchas a pledget, button, or other structure that provides a footprintagainst the epicardial surface to resist retraction of the control wire300 into the ventricle. The control wire 300 may thereafter be severedproximally of its securement to the anchor 322, leaving the control wire300 and anchor 322 in position to span the ventricle and retain theconfiguration of the implant as illustrated in FIG. 48D.

In all the foregoing embodiments, the final configuration of the implantwithin the mitral valve is illustrated in a highly schematic form, andthe angle and degree of inclination into the direction of the ventriclemay be significantly greater than that illustrated herein depending uponthe desired clinical performance. The transvalvular band inclination canbe highly advantageous in some embodiments in providing clinical benefitas it facilitates “physiologic coaptation” in a preferred manner as itssurface mimics the three dimensional feature created by the leaflets asthey would have coapted in a healthy native valve.

Referring to FIGS. 49A through 49H, there is illustrated a transapicalapproach to the mitral valve, and deployment of a transvalvular band inaccordance with the present invention. As illustrated in FIG. 49A, adeployment catheter 320 has been introduced such as via thoracotomy, andadvanced retrograde through the mitral valve. A transvalvular band 324has been deployed distally from the catheter 320, and is illustrated inFIG. 49A in an expanded configuration within the left atrium. Expansionof the transvalvular band 324 from a reduced cross-sectional profile forpositioning within the catheter 320 to the enlarged cross-sectionalprofile illustrated in FIG. 49A may be accomplished either undermechanical force, such as by dilatation of an inflatable balloon orother mechanical mechanism. Preferably, however, transvalvular band 324is self-expandable so that it converts from the reduced profile to theenlarged profile automatically upon deployment from the distal end ofthe catheter 320.

In the illustrated embodiment, the transvalvular band 324 comprises anarcuate central portion 325, which is convex in the direction of theventricle. See FIGS. 49A and 49B. The transvalvular band 324 is providedwith a first attachment structure 326 and a second attachment structure328. Attachment structures 326 and 328 may comprise any of a variety ofstructures disclosed herein, such as tissue anchors, including hooks orbarbs. In one implementation of the invention, the first attachmentstructure 326, and second attachment structure 328 each comprise atarget for receiving an anchor as will be disclosed below. Suitabletargets for the present purpose include woven or non-woven fabrics,polymers, or other materials or constructions which permit a needle orsharpened anchor to penetrate therethrough, as will be discussed. In oneimplementation of the invention, each of the attachment structurescomprises a Dacron mesh, having a frame for supporting the mesh andsecuring the mesh to the transvalvular band 324.

Referring to FIG. 49B, there is illustrated a perspective view of thetransvalvular band 324 illustrated in FIG. 49A. The transvalvular band324 comprises a central section 325, convex in the direction of theventricle for affecting leaflet closure as has been described herein.Central section 325 is formed by a frame 327, which comprises at leastone strut 329 extending between the first attachment structure 326 andsecond attachment structure 328. In the illustrated embodiment, threestruts extend generally parallel to each other, defining at least twoelongate openings therebetween. One or two or four or more transverseelements 331 may be provided, such as to enhance structural integrity ofthe construct. At least a first control wire 300 and, optionally asecond or third or fourth control wire 300 is releasably attached to thetransvalvular band 324, to enable manipulation of the band into positionas shown in FIG. 49C. Control wire 300 is releasably connected to thetransvalvular band 324 at a connection point 301. The connection atpoint 301 may be established by threadable engagement, anelectrolytically detachable link or weld, or other detachment mechanism.Electrolytically detachable deployment systems are know, among otherplaces, in the neurovascular embolic coil and stent arts, and suitablesystems are disclosed in U.S. Pat. No. 5,976,131 to Guglielmi, et al.;U.S. Pat. No. 6,168,618 to Frantzen; and U.S. Pat. No. 6,468,266 toBashiri, et al., the disclosures of which are hereby incorporated intheir entireties herein by reference

The first attachment structure 326 comprises a support 333 carried bythe frame 327. In the illustrated embodiment, support 333 comprises anenclosed loop, having a central opening filled or covered by a mesh 337.The support 333 may alternatively comprise any of a variety ofstructures, such as a single linear element, sinusoidal or zigzagpattern, depending upon the desired performance. In the illustratedembodiment, the support 333 is conveniently provided in the form of aloop, to facilitate holding mesh 337 in a generally planarconfiguration, and support the mesh so that it may be punctured by ananchor, suture or other retention structure. A second support 335 issimilarly provided with a mesh 337, to facilitate attachment. The mesh337 may conveniently be a layer or pad of Dacron or other material, suchas an integration of a silicone core with a Dacron jacket, whichfacilitates both piercing by an attachment structure, as well as tissuein-growth for long term retention. The first support 333 and secondsupport 335 may comprise a radio opaque material, or be provided withradio opaque markers to enable aiming the anchor deployment system intothe mesh 337 under fluoroscopic visualization.

Once the transvalvular band 324 has been brought into the positionillustrated in FIG. 49C, the first attachment structure 326 and secondattachment structure 328 may be secured to the adjacent tissue using anyof a variety of clips, staples, barbs, sutures, or other structure whichmay be conveniently pierced through the mesh 337 and/or looped aroundthe first and second supports 333, 335. The retention element may beapproached from either the side of the left atrium, the ventricle, orepicardially, such as by way of a minimally invasive puncture on thechest wall. In the implementation of the method described below, theexample of advancing the retention elements from the left ventricle willbe described.

Referring to FIG. 49C, proximal traction on the catheter 320 and on thecontrol wire 300, pulls the transvalvular band 324 snuggly against theleft atrial side of the mitral valve, such that the first attachmentstructure 326 and second attachment structure 328 are seated against thevalve annulus.

Referring to FIG. 49D, a first anchor guide 330 and a second anchorguide 332 have been distally advanced from the distal end of thecatheter 320. Anchor guides 330 and 332 may be alternatively associatedwith or carried by the catheter 320 in a variety of ways. For example,the first and second anchor guides 330 and 332, may be pivotably carriedby the catheter 320, such that they may be inclined radially outwardlyfrom the longitudinal axis of the catheter in the distal direction.

In the illustrated embodiment, the first and second anchor guidescomprise a wire or tube for directing an anchor as will be discussed.The wire or tube of the anchor guide may comprise any of a variety ofmaterials, such as nickel titanium alloys (e.g. nitinol) which may bepreset to assume a position similar to that illustrated in FIG. 49D upondistal advance from the catheter 320. The first and second anchor guidesmay be provided with radio-opaque markers, or may be constructed from aradio-opaque material, to permit fluoroscopic guidance. In theillustrated embodiment, the first and second anchor guides are in theform of tubes, for axially slidably receiving a tissue anchor and tissueanchor deployment structures therein.

Referring to FIG. 49E, a retention element in the form of a first anchor334 is illustrated as having been distally advanced from the firstanchor guide 330, through the tissue in the vicinity of the mitral valveannulus, and through the first attachment structure 326. Penetration ofthe first anchor 334 through the first attachment structure 326 may beaccomplished while providing proximal traction on the control wire 300.

The first anchor 334 is provided with at least one and preferably two orfour or more transverse elements 336 to resist proximal retraction ofthe first anchor 334 back through the opening formed in the firstattachment structure 326. The transverse element or surface 336 may beprovided on any of a variety of structures, such as an umbrella-typestructure, t-tag, barbs, or other anchoring configuration which can passin a first direction through an opening formed in the first attachmentstructure 326, but resist retraction in a second, opposite direction,back through the first attachment structure 326.

The transverse element 336 is carried by a filament 338, which extendsthrough the adjacent myocardial tissue. Filament 338 may comprise any ofa variety of materials, such as a monofilament or multi-filamentstructure made from polypropylene, any of a variety of other knownsuture materials such as polyethylene, or metals such as stainlesssteel, nitinol, and others known in the art. The filament 338 may be amono-filament structure or a multi-filament structure which may bebraided or woven, depending upon the desired clinical performance. Atleast a second, similar anchor 340 is introduced on the opposing side ofthe mitral valve.

Referring to FIG. 49F, a second transverse element 342 is shown securedto or carried by the ventricular end of the filament 338, to provide asecure anchoring through the tissue wall for the transvalvular band. Asimilar structure is provided on the opposing side of the mitral valve.Although only a first and second anchoring systems has been describedabove, additional anchoring systems, such as a total of four or six oreight or more, typically in even numbers to produce bilateral symmetry,may be used. The number and configuration of tissue anchors will dependupon the configuration of the transvalvular band, as will be apparent tothose of skill in the art in view of the disclosure herein.

As shown in FIG. 49F, the anchors have been fully deployed and the firstanchor guide 330 and second anchor guide 332 have been proximallyretracted into the catheter 320.

Referring to FIG. 49G, the control wire 300 may thereafter be detachedfrom the transvalvular band and removed. Detachment of control wire 300may be accomplished in any of a variety of ways, as has been describedelsewhere herein.

Alternatively, the control wire 300 may be left in place as isillustrated in FIG. 49H. Control wire 300 is secured to an epicardialanchor 322, to provide a transventricular truss, as has been described.

Referring to FIGS. 50A and 50B, there is illustrated a side elevationalschematic view of the distal end of a deployment catheter 360 which maybe adapted for use in either the transapical delivery of FIGS. 49A-49H,or any other delivery mode described herein. In the illustratedembodiment, the deployment catheter 360 includes an elongate tubularbody having a central lumen 362, opening at a distal end 364. Carriedwithin the central lumen 362 is a transvalvular band 366, in a rolled-upconfiguration. Transvalvular band 366 is maintained in a rolled-upconfiguration by the constraint imposed by the deployment catheter 360.However, upon distal advance of the push element 368 to deploy thetransvalvular band 366 beyond the distal end 364, as illustrated in FIG.50B, the transvalvular band 366 unrolls under its natural bias into apredetermined configuration for implantation across the mitral valve.

One configuration for the transvalvular band is shown rolled out in planview in FIG. 51A. However, any of a variety of alternative transvalvularband configurations disclosed herein can be utilized with the catheterof FIGS. 50A and 50B.

Referring to FIG. 51A, there is illustrated a transvalvular band 366having a central portion 368 for spanning the coaptive edges of themitral valve. A first attachment zone 370 and a second attachment zone372 are provided on opposing ends of the central portion 368.

The central portion comprises at least a first strut 374 for spanningthe mitral valve as has been discussed. In the illustrated embodiment, asecond strut 376 and a third strut 378 are provided, spaced apart toincrease the width of the contact footprint with the valve leaflet butpermit blood flow therethrough. A first end of each of the struts 374,376, and 378 are connected at the first attachment zone 370, and thesecond ends of the three struts are connected at the second attachmentzone 372.

The first and second attachment zones may be provided with a reinforcingelement 382, to facilitate long term attachment. Apertures 380 areillustrated, which may be provided to allow manual suturing when thetransvalvular band 366 is intended for use in an open surgicalprocedure. Alternatively, apertures 380 may be configured for attachmentusing an anchor deployment catheter when intended for use in atranslumenal or transapical deployment. Each of the first, second andthird ribs may be provided with a central core, such as a nitinol orstainless steel wire or ribbon, and an outer coating such as apolycarbonate urethane with or without copolymers like silicone,silicone coating, or a fabric such as PET, ePTFE, polyethylene, or ahybrid of, for example, the aforementioned materials impregnatedsilicone coating, to reduce the risk of abrasion of the mitral valveleaflets A close-up view of circled zone 51D of FIG. 51A is illustratedin FIG. 51D.

FIG. 51D illustrates one embodiment of a fatigue-resistant terminalportion of a proximal and/or distal end of one, two, or more of thestruts 374, 376, 378 illustrated in FIG. 51D. The terminal portion 51Dmay have a non-linear portion 378′ and a head portion 379. Thenon-linear portion could be a coil with a helical, zig-zag, or any othergenerally non-linear shape to advantageously provide increased fatigueresistance for the struts. In some embodiments, at least a portion ofthe terminal portion 51D is embedded in an elastomer such as silicone,polycarbonate, urethane, or the like to further improve fatiguetolerance. In some embodiments, the terminal portion 51D may have astraight-line length that is less than 20%, 15%, 10%, 5%, or less of thestrut. In some embodiments, the terminal portion 51D may have astraight-line length that is at least about 5%, 10%, 15%, 20%, 25%, ormore of the length of the strut, or could even cover the entire lengthof one, two, or more struts 374, 376, 378 from first attachment zone 370to second attachment zone 372 (e.g., a strut without a linear portion).Head portion 379 is operably connected to non-linear portion 378′ andthe portions may be integrally formed. The head portion 379 could bespherical, ovoid, square, rectangular, triangular, or a variety of othershapes. Head portion 379 is in turn operably connected to firstattachment zone 370 and/or second attachment zone 372. In someembodiments, the head portion 379 is not attached to an attachment zonebut rather terminates as a free end of one or more of the struts 374,376, 378.

FIG. 51B is a side elevational view of the transvalvular band 366 ofFIG. 51A, shown in a flat configuration. However, as has been discussedelsewhere herein, the transvalvular band will typically be provided witha curvature such that it advances the mitral valve leaflets in thedirection of the ventricle and provides for physiologic coaptation.

FIG. 51C illustrates a perspective view of a transannular band 366 in arolled-up configuration for delivery, similar to that illustrated inFIG. 50B. The band can be rolled in a variety of ways, such as capturingthe band 366 at or near the center (near 363) and rolling it such thatboth ends are drawn inward as shown. In some embodiments, the band couldbe rolled up like a scroll, or folded into a “V”, “W”, or a variety ofother shapes. In some embodiments, at least a portion of the band 366resides within one or more slots 363 or movable jaw-like elements on thedistal end 363 of a mandrel 367 or other elongate body within a deliverycatheter. Actuation of the jaw-like elements to release the band 366,distal movement of a pusher tube, retraction of the mandrel 367 relativeto another catheter, or other mechanism can be employed to deploy theband 366. In some embodiments, turning the mandrel a desired distance,such as about 90 degrees, can help facilitate unfurling of the band 366for deployment.

Referring to FIGS. 52A-52C, there is illustrated a transvalvular band inaccordance with the present invention having a tissue attachment systemwhich may be adapted for either percutaneous or open surgical use. Thetransvalvular band comprises a central zone 368 carrying a firstattachment zone 370 and a second attachment zone 372 as has beendescribed.

A tissue anchor 390, such as a “t-tag” anchor includes a transverseelement 392 and an elongate flexible suture 394. As used herein, theterm “suture” is not limited to its normal definition, but also includesany of a wide variety of elongate flexible filaments, includingpolymeric, metal, combinations of both as well as monofilament andmultifilament structures. Multifilament structures may be braided,woven, or otherwise configured, depending upon the desired performance.

The suture 394 is illustrated to extend through a first guide 396 in thesecond attachment zone 372. For simplicity, only a single anchoringsystem will be disclosed herein. However, it should be appreciated thatthe anchoring system may be utilized on both ends of the central zone368, and more than one, such as two or three or more, anchors 390 may beutilized on each attachment zone.

The suture 394 is illustrated as extending through first guide 396, andthen through a lock 398 which will be described below. The free end 402of the suture 394 is further advanced through a second guide 400.Depending upon the intended use of the system, the free end 402 mayextend proximally throughout the length of the deployment catheter,where it may be manipulated such as by proximal traction in order totighten the second attachment zone 372 with respect to the transverseelement 392. Thereafter, the free end 402 may be severed in the vicinityof the second attachment zone 372 or elsewhere.

Referring to FIG. 52C, details of the lock 398 may be seen. In general,the lock 398 includes an aperture 404 through which the suture 394 mayextend. An engaging element 406 is exposed to the interior of theaperture, for permitting the suture to advance in a first directionthrough the aperture 404 but resist movement of the suture 394 in anopposite direction through the aperture 404. In the illustratedembodiment, the engaging element 406 is a sharpened point or spikeconfigured to mechanically pierce or engage the suture 394.

The foregoing structure permits the free end 402 to be proximallywithdrawn away from the second attachment zone 372 in a manner thatdraws the transverse element 392 closer to the second attachment zone372. However, traction on the transverse element 392 causes the suture394 to engage the engaging element 406, and prevents the transverseelement 392 from pulling away from the second attachment zone 372.

Referring to FIG. 52D, illustrated is a suture 394 which can be loopedthrough one, two, or more transverse elements 392 of anchors. The suture394 looped through the anchor can function as a pulley, whereappropriate traction on the suture 394 can tighten the anchors intoplace. Having a plurality of anchors as shown connected on one loop,such as, for example, 2, 3, 4, 5, or more anchors, can advantageouslyallow one cinching maneuver to tighten all of the anchors at once.

Referring back to FIG. 52A, an anchor deployment tool 408 isillustrated. Deployment tool 408 may comprise an elongate flexible wirehaving a proximal end 410 and a distal end 412. The deployment tool 408may extend throughout the length of a percutaneous translumenalcatheter, with the proximal end 410 exposed or attached to a control toallow axial reciprocal movement of the deployment tool 408. The distalend 412 is releasably positioned within an aperture 414 on a first endof the transverse element 392. A second end of the transverse element392 is provided with a sharpened point 416.

In use, distal axial advance of the deployment tool 408 is utilized todrive the transverse element 392 into a target tissue, to a desireddepth. Once the desired depth has been achieved, proximal retraction onthe deployment tool 408 proximally retracts the distal end 412 out ofthe aperture 414, allowing removal of the deployment tool 408 butleaving the transverse element 392 behind within the target tissue.Proximal traction on the free end 402 of the suture 394 enablestightening of the transvalvular band with respect to the transverseelement 392. Once a desired level of tightening has been achieved,releasing the free end 402 allows engaging element 406 to lock thesuture 394 against further release, thereby holding the transvalvularband into position.

Although the lock 398 is illustrated as an enclosed aperture,alternative lock embodiments may involve access from a lateral edge ofthe implant. This permits side-loading of the suture into the lock,which may in some instances be desired over an enclosed aperture whichrequires end loading of the suture through the aperture. A variety ofalternative side-loading lock configurations is illustrated in FIG. 53.

Referring to FIG. 54, there is illustrated a perspective view of analternate transvalvular band in accordance with the present invention.In this embodiment, the central section 368 is provided with anasymmetrical curvature, to provide asymmetrical support to the mitralvalve leaflets. Along the width or central portion of the transvalvularband, this provides a contour mimicking the three-dimensional shape ofthe coapted mitral valve in a healthy native valve, and provides aphysiologic analog thereby promoting correct anatomy during coaptation.

FIGS. 55 and 56 illustrate alternative transvalvular bands in accordancewith the present invention. In these embodiments, the attachment zonesare provided with tissue anchors configured to pierce the tissue of thevalve annulus. In general, the tissue anchors each comprise a pointedend, for penetrating tissue and a retention structure for resistingremoval of the tissue anchor from the tissue. The retention element inFIG. 55 is in the form of a first or second barb or shoulder, as will beunderstood by those skilled in the art. The retention feature of thetransvalvular band illustrated in FIG. 56 comprises an arcuateconfiguration for the tissue-piercing structure. Compression from theclosure of the valve leaflets against the convex side of the centralzone will tend to impart a circumferential force on the tissue anchors,advancing the distal point further in the direction of its own arcuatepath. This construction tends to allow the natural forces of closure ofthe mitral valve to increase the retention of the tissue anchor withinthe adjacent tissue. In some embodiments, the barbs can be used as aprimary anchor that can be crimped or otherwise secured in place. Inother embodiment, the barbs could act as positioning features, totemporarily hold the band in place while verifying the position. Theband could then be anchored in a secondary step, such as using a crimp,staple, suture, or other anchor as described herein. In someembodiments, the barbs can be self-locking upon penetration throughtissue.

In some embodiments, disclosed is a transvalvular band that providesresistance to coaptation in the same manner as the chordae providesresistance to coaptation in a continuously nonlinear fashion, like aviscoelastic response. This band could have a configuration such asdescribed and illustrated above, and could have material properties oradditional features to provide non-linear resistance to coaptation. Suchembodiments could retain a curvature mimicking the natural threedimensional surface of the coapted mitral valve yet could displace inthe retrograde direction up to the anatomically correct plane ofcoaption when appropriate. The direction of displacement, for example,with respect to the mitral valve is better described in the atrialdirection during systole to provide a cushioned impact for the valveleaflets as opposed to the leaflets striking a ridged implant structureand remodeling in a potentially deleterious fashion such as fibrosis orthinning around impact edges. FIG. 56A is reproduced from Nielsen et al,Circulation 2003; 108:486-491, Influence of Anterior Mitral LeafletSecond-Order Chordae Tendineae on Left Ventricular Systolic Function,which is hereby incorporated by reference in its entirety, illustratinga bilinear relationship between LV pressure and chordal tension duringisovolumic contraction, a decrease in chordal tension despite high LVpressure during ejection, and an almost linear decline during isovolumicrelaxation. FIG. 56B is reproduced from Nielsen et al, J ThoracCardiovasc Surg 2005; 129:525-31, Imbalanced chordal force distributioncauses acute ischemic mitral regurgitation: Mechanistic insights fromchordae tendineae force measurements in pigs, which is incorporated byreference in its entirety. These figures demonstrate that chordae forcewith respect to time increases and then decays in a non-linear mannerduring systole. A band mimicking this performance could benefit thevalvular surface as it returns its coaptive forces to a near normalstate. In some embodiments, a band could cushion or physiologicallyreduce or prevent physical stress caused by repetitive contact with thecoaptive leaflet surfaces. The band could accomplish this by virtue ofconstruction such as chambered struts that may or may not be filled witha media such as a fluid. These chambers would be enclosed andimpermeable or substantially impermeable to blood or blood componentpenetration within a lifetime. Another method of cushioned coaptionwould be a device that allows some flexing during coaption. Thisflexibility could be designed based upon strut material, thickness,width, inferior and superior cross-section such as a ripple, orencapsulation material such as an elastomer or elastomeric foam. Thefoam material could be sealed by an exterior polymer of equal overallflexibility. Additional embodiments would be coils (such as illustratedin FIG. 51D above) or coils within coils to produce unique nonlineardisplacement signatures or tubes such as Nitinol laser cut tubes thatcould optionally be filled with a polymer. Yet another embodiment wouldinclude struts that loop towards the ventricle crossing itself. Thisloop would also create this nonlinear resistance to coaption by itsspring force. In other embodiments, the band can proceed down to thechordae and devices can be adapted to shorten or augment the chordae toachieve natural physiology. Devices of this manner can be, for example,crimped bands with elastomer bodies between the crimped bands. Theelastomeric bodies would replicate the deficient portion of the chordaeto mimic the correct force curve during coaptation. This may provideenough benefit in some grades of the disease so as to provide palliativecare or resolve it.

Any of a wide variety of specific tissue anchor constructions may beutilized in combination with the transvalvular band of the presentinvention. In addition, a variety of features have been described asillustrative in connection with a variety of implementations of theinvention. Any of the features described above, may be recombined withany other of the embodiments disclosed herein, without departing fromthe present invention, as should be apparent to those of skill in theart.

While the foregoing detailed description has set forth several exemplaryembodiments of the apparatus and methods of the present invention, itshould be understood that the above description is illustrative only andis not limiting of the disclosed invention. It will be appreciated thatthe specific dimensions and configurations disclosed can differ fromthose described above, and that the methods described can be used withinany biological conduit within the body.

1-20. (canceled)
 21. A system, comprising: a delivery catheter; and atransvalvular intraannular implant comprising an elongate body having alongitudinal axis from a first end to a second end, wherein thetransvalvular intraannular implant is configured to be transformablefrom a first reduced configuration to a second enlarged configuration,wherein the transvalvular intraannular implant is configured to behoused within the delivery catheter in the first reduced configuration,wherein the transvalvular intraannular implant is configured to betransformed to the second enlarged configuration within a heart of apatient and positioned such that the transvalvular intraannular implantis oriented in the heart such that the longitudinal axis of thetransvalvular intraannular implant is oriented substantiallytransversely to a coaptive edge of a heart valve, wherein thetransvalvular intraannular implant comprises a first connection sectioncomprising at least one eyelet and a second connection sectioncomprising at least one eyelet, each connection section tapering inwardtoward a central section.
 22. The system of claim 21, further comprisingat least one tissue anchor.
 23. The system of claim 21, wherein thetransvalvular intraannular implant is formed from a single length ofwire.
 24. The system of claim 21, wherein the central section is shapedto reduce resistance to blood flow from the atrium to the ventricle. 25.The system of claim 21, wherein the heart valve comprises two leaflets.26. The system of claim 21, wherein the heart valve comprises threeleaflets.
 27. The system of claim 21, wherein the transvalvularintraannular implant does not comprise an annuloplasty ring.
 28. Thesystem of claim 21, wherein the transvalvular intraannular implant isformed from several lengths of wire.
 29. The system of claim 21, whereinthe central section is curved downward.
 30. The system of claim 21,wherein the transvalvular intraannular implant is configured to treatleaflet prolapse.
 31. A system, comprising: a delivery catheter; and atransvalvular intraannular implant comprising an elongate body having alongitudinal axis from a first end to a second end, wherein thetransvalvular intraannular implant is configured to be transformablefrom a first reduced configuration to a second enlarged configuration,wherein the transvalvular intraannular implant is configured to behoused within the delivery catheter in the first reduced configuration,wherein the transvalvular intraannular implant is configured to betransformed to the second enlarged configuration within a heart of apatient and positioned such that the transvalvular intraannular implantis oriented in the heart such that the longitudinal axis of thetransvalvular intraannular implant is oriented substantiallytransversely to a coaptive edge of leaflets, wherein transvalvularintraannular implant comprises a first connection section comprising atleast one eyelet and a second connection section comprising at least oneeyelet, each connection section connected to a central section having anarcuate shape.
 32. The system of claim 31, wherein the arcuate shapebows in the direction of the ventricle.
 33. The system of claim 31,wherein the arcuate shape is configured to achieve early closure of theleaflets.
 34. The system of claim 31, wherein the transvalvularintraannular implant comprises a flexible wire.
 35. The system of claim31, wherein the transvalvular intraannular implant comprises orientedstruts.
 36. The system of claim 31, wherein bend angles of thetransvalvular intraannular implant are configured to be altered.
 37. Thesystem of claim 31, wherein the transvalvular intraannular implantcomprises an axis of compression.
 38. A system, comprising: a deliverycatheter; a transvalvular intraannular implant comprising an elongatebody having a longitudinal axis from a first end to a second end,wherein the transvalvular intraannular implant is configured to betransformable from a first reduced configuration to a second enlargedconfiguration, wherein the transvalvular intraannular implant isconfigured to be housed within the delivery catheter in the firstreduced configuration, wherein the transvalvular intraannular implant isconfigured to be transformed to the second enlarged configuration withina heart of a patient and positioned such that the longitudinal axis ofthe transvalvular intraannular implant is oriented relative to a firstleaflet and a second leaflet, wherein transvalvular intraannular implantcomprises a first connection section comprising a first connectionsection eyelet and a second connection section comprising a secondconnection section eyelet; and a first anchor configured to secure thefirst connection section eyelet to the first leaflet and a second anchorconfigured to secure the second connection section eyelet to the secondleaflet.
 39. The system of claim 38, wherein the transvalvularintraannular implant is configured to provide a relatively large supportfootprint against the first leaflet and the second leaflet, while at thesame time optimizing the area of open space to permit maximum blood flowtherethrough.
 40. The system of claim 38, wherein the transvalvularintraannular implant comprises a flexible material.